BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3211891 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95454
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING LOW BLOOD GLUCOSE, AND HE STATED THAT THE INSULIN PUMP WAS GIVING HIM TOO MUCH INSULIN OVER THE WEEKEND. THE CUSTOMER'S BLOOD GLUCOSE WAS 172MG/DL WITH 60 CARBOHYDRATES, AND THE INSULIN PUMP TRIED TO GIVE HIM OVER 6.0 UNITS OF INSULIN WITH A SENSITIVITY FACTOR OF 30. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE PROGRAMMING, AND FOUND THAT THE TIME WAS OFF WITH FIFTEEN MINUTES. ASSISTED THE CALLER WITH CORRECTING IT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308647 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR